(256 days)
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No
The summary describes a qualitative in vitro diagnostic test for genotyping specific mutations and variants in the CFTR gene. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The focus is on identifying specific genetic markers.
No
The device is an in vitro diagnostic test for genotyping mutations; it does not treat or cure any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device comprises "qualitative in vitro diagnostic devices" and is intended for "confirmatory diagnostic testing of newborns and children."
No
The device is described as an in vitro diagnostic device that uses genomic DNA isolated from human peripheral whole blood. This indicates the use of physical reagents and laboratory equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Verigene CFTR and Verigene®CFTR PolyT Nucleic Acid Tests are qualitative in vitro diagnostic devices used to genotype a panel of mutations and variants..."
This directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Verigene CFTR and Verigene®CFTR PolyT Nucleic Acid Tests are qualitative in vitro diagnostic devices used to genotype a panel of mutations and variants in the cystic fibrosis transmembrance regulator (CFFT) gene in genomic DNA isolated from human peripheral whole blood. The Verigene CFTA Nucleic Acid Test provides information intended to be used for carrier testing in adults of reproductive age and in confirmatory diagnostic testing of newborns and children.
These tests are not indicated for use in fetal diagnostic or pre-implantation testing and not indicated for stand-alone diagnostic purposes. The results should be used in conjunction with other available laboratory and clinical information.
Product codes
NUA
Device Description
The Verigene® CFTR and Verigene® CFTR PolyT Nucleic Acid Tests are qualitative in vitro diagnostic devices.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Adults of reproductive age, newborns, and children.
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5900 Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
(a)
Identification. The CFTR gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the CFTR gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation, or population screening.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System.” See § 866.1(e) for the availability of this guidance document.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
JUL 8 4 2009
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Nanosphere, Inc. c/o Dr. Gregory W. Shipp Vice President, Medical and Regulatory Affairs and Quality Assurance 4088 Commercial Avenue Northbrook, IL 60062
Re: K083294
Trade/Device Name: Verigene® CFTR and Verigene® CFTR PolyT Nucleic Acid Test Regulation Number: 21 CFR 866.5900 Regulation name: CFTR (cystic fibrosis transmembrane conductance regulator) gene mutation detection system Regulatory Class: Class II Product Code: NUA Dated: June 19, 2009 Received: June 22, 2009
Dear Mr. Shipp,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial
1
Page 2 - Mr. Gregory Shipp
equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office or In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Reena. Philip
Cor Maria M. Chan, Ph.D. Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for use
510(k) Number (if known): K083294
Device Names: Verigene® CFTR and Verigene® CFTR PolyT Nucleic Acid Tests
Indications for Use:
The Verigene CFTR and Verigene®CFTR PolyT Nucleic Acid Tests are qualitative in vitro diagnostic devices used to genotype a panel of mutations and variants in vitro
transmembrance regulator (CFTA) consisted institute and variants in the cystic fibrosis transmission is see about to the of micrations and variants in the cystic fibrosis
transmembrance regulator (CFFT) gene in genomic DNA isolated from human peripheral whole blood (CF7 / ) gene includes mutations and variations and variations and virus and virus and variations and variations and variations and Obstericians and Gyneologists (ACOG). The Verigene CFTA Nucleic Acid Test provides information intended to be used for carrier testing in adults of reproductive age and in confirmatory diagnostic testing of newborns and children.
These tests are not indicated for use in fetal diagnostic or pre-implantation testing and not indicated for stand-alone is in retal dagnostic of pre-implantation testing and not
indicated for stand-alone diagnostic purposes. The results should be used in conjunction w other available alono diagnostic purposes. The results should be used in conjunction with
other available laboratory and clinical information. Both tests are intended to be u
Prescription Use × (Part 21 CFR 801 Subpart D)
and/or
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Reena Philip
For Maria Chao)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083294